Instrument for optical tissue interrogation

ABSTRACT

A surgical system includes a light source, a sensor for detecting light, and a surgical device including an elongate shaft having a distal part positionable at a surgical working site within a body cavity. A first optical pathway transmits light from the light source to a distal part of the elongate shaft and onto tissue within the body cavity, and a second optical pathway receives light from tissue within the body cavity and transmits the received light to the sensor. A surgical barrier, such as one covering a robotic manipulator arm housing components of the system, is positioned such that at least the first or second optical pathway includes an optically transmissive portion of the surgical barrier.

This application is a continuation of U.S. Ser. No. 15/917,898, filedMar. 12, 2018, which claims the benefit of U.S. provisional applicationNo. 62/470,125, filed Mar. 10, 2017.

FIELD OF THE INVENTION

The invention relates generally to use of optical interrogation fordetermining tissue information during a surgical procedure andcommunicating optical information to/from an instrument through asterile drape.

BACKGROUND

There are several methods and systems for using multi- or hyper-spectralimaging for in vivo tissue diagnosis. These allow users tointra-operatively distinguish between different types of tissue, whetherdifferent organs, vessels or even cancerous versus benign tissue. Manyof these techniques and systems are used in the endoscopic field as analternative to biopsies.

There are various types of surgical robotic systems on the market orunder development. Some surgical robotic systems use a plurality ofrobotic arms. Each arm carries a surgical instrument, or the camera usedto capture images from within the body for display on a monitor. Othersurgical robotic systems use a single arm that carries a plurality ofinstruments and a camera that extend into the body via a singleincision. These types of robotic system use motors to position andorient the camera and instruments and, where applicable, to actuate theinstruments. Input to the system is generated based on input from asurgeon positioned at master console, typically using input devices suchas input handles and a foot pedal. Motion and actuation of the surgicalinstruments and the camera is controlled based on the user input. Theimage captured by the camera is shown on a display at the surgeonconsole. The console may be located patient-side, within the sterilefield, or outside of the sterile field.

This application describes configurations of surgical instruments havingoptical interrogation features, and configurations for using suchinstruments in surgical robotic systems.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1(a) illustrates a system including an instrument with sensingcapabilities for optical interrogation of tissue. This embodiment isconfigured to optically transmit light through a surgical drape disposedbetween the fiber optics of the instrument and the light source andsensor components.

FIGS. 1(b), 1(c), 1(d) show alternate tip arrangements for theinstrument of FIG. 1(a).

FIG. 1(e) shows the instrument of FIG. 1(a) incorporated into a roboticsurgical system.

FIG. 2 illustrates a second embodiment of a system including aninstrument with sensing capabilities for optical interrogation oftissue, including one or more remote module(s) connected by cables tothe instrument and housing the light source and sensor.

FIG. 3 illustrates a third embodiment of system including an instrumentwith sensing capabilities for optical interrogation of tissue, includingan optical module carried by the instrument.

FIG. 4 shows an arrangement of optical components that may be used ininstruments of the type described herein to allow light for illuminatingand sensing to be carried by the same optical fiber.

FIG. 5 shows an arrangement of optical fibers that may be used ininstruments of the type described herein.

FIG. 6 shows an alternative embodiment of an instrument incorporatingparallel jaw motion.

FIG. 7 shows an alternative embodiment configured to provide informationalong the edges of a surgical instrument.

FIG. 8 is a schematic block diagram illustrating components of anexemplary surgical system according to the disclosed embodiments.

DETAILED DESCRIPTION

This application describes surgical systems that make use of surgicalinstruments that can obtain information about body tissues in theoperative working space during a surgical procedure. The tissueinformation is derived based on an optical interrogation meansintegrated into the surgical instrument. The tissue information can beused for tissue identification, tissue differentiation, diagnosis, andidentification of fragile structures (nerves, ducts, blood vessels)prior to dissection or cauterization. In the case of cauterization,using optical interrogation to confirm the presence of a blood vesselbetween the jaws prior to cautery and to subsequently confirm hemostasiscould improve the efficacy of cautery and minimize collateral tissuedamage. Tissue information obtained using the instruments can be usefultowards aiding the surgeon in creating adequate tumor margin whenremoving tumors in oncologic surgery, identifying cancerous lesions,identifying nerve or other fragile tissues or tissue structures prior todissection. The optical interrogation function can be included oninstruments having a treatment delivery mechanism such as therapeuticadministration of optical energy. Optical energy administration may beused in combination with a suitable binding agent to enhancesite-specificity.

Other types of tissue information that can be obtained or derivedinclude tissue density, inflammation, ischemia, and blood vesselpresence (via transmittance loss, hemoglobin detection, blood flowdetection).

A surgical system 100 according to disclosed embodiments, shownschematically in FIG. 8, comprises a light source 102, a sensor 104 fordetecting light, and a surgical instrument 106. The instrument includesa distal part positionable at a surgical working site within a bodycavity, a first optical pathway for transmitting light from the lightsource to the distal part and onto tissue within the body cavity, and asecond optical pathway for receiving light from tissue within the bodycavity (light that is reflected or, in the case of some modalities suchas fluorescence, emitted, from the tissue in response to illumination)and transmitting the received reflected/emitted light to the sensor 104.The system further includes a processor that receives from the sensorsignals that are indicative of the light detected by the sensor. Theprocessor is configured to analyze the signals to derive or determinetissue information using algorithms appropriate for the particularoptical interrogation modality. The determined tissue information may becommunicated to the user in a variety of ways, including those describedin commonly-owned U.S. application Ser. No. 15/917,897 entitledCOMMUNICATION OF DETECTED TISSUE CHARACTERIZATION IN A SURGICAL ROBOTICPLATFORM filed on the same day as the present application.

The imaging means or sensor may be an image sensor, camera, orspectrometer. The sensor may be used for direct imaging of the region ofinterest, or in other types of sensing such as fluorescence imaging,time-resolved fluorescence spectroscopy, time-resolved infraredspectroscopy, diffuse-reflectance spectroscopy (DRS) which can be usedfor tissue differentiation, photoacoustic tomography (PAT), Ramanspectroscopy, or optical coherence tomography (OCT)). In someembodiments, ultrasound or ultrasound elastography might be used in lieuof the optical modalities, or as an additional modality. Ultrasoundelastography has been used, for example, to determine tissue informationcorresponding to the stiffness or elasticity of tissue. In instrumentsusing ultrasound rather than optical modalities, the sensor is anultrasound transducer rather than means for sensing light orelectromagnetic radiation. Some instruments might be equipped for bothoptical interrogation and other interrogation modalities such asultrasound.

The robotic surgical system may be of the types described in theBackground section or another type of robotic system.

A first embodiment is shown in FIG. 1(a) and includes a surgicalinstrument having a distal part 12 and an elongate shaft 14. The systemincludes an optical module 15 comprising a source of light 16 (which mayinclude one or more light sources) and a sensor 18 (which may optionallyinclude a lens assembly 13). Light from the source 16 is transmitted tothe distal part of the surgical instrument via an optical fiber or abundle of optical fibers 17 b, and light reflected or transmitted ontothe tip of the instrument is transmitted to the image sensor 18 via anoptical fiber or a bundle of optical fibers 17 a running through theinstrument shaft 14. An optional optical expander 11 is shown at theproximal end of the optical fiber cable 17 a. Alternatives to thisoptical fiber configuration are discussed below in connection with FIGS.4 and 5.

In this embodiment, the proximal part of the optical path (defined bythe optical fibers/bundles and any associated optical expanders) isdisposed on one side of a surgical drape 20, while the source 16 andsensor 18 are on the opposite side of the drape 20. In other words,light communicated from/to these fibers is transmitted through the drape20. The drape may be constructed in its entirety of a material havingsuitable optically transmissive properties, or it might include a windowformed of material having suitable optically transmissive properties.

The distal part of the instrument may include jaw members 22 a, 22 b asshown. The distal ends of the optical fibers/bundles are exposed at theassociated jaw member (optionally via an aperture in the jaw) or inoptical communication with transmissive windows that are exposed in thejaw member. Transmission of light may be directed from one jaw towardsthe other jaw (see FIG. 1(b) and FIG. 1(d)), or it might be forwardlooking onto the tissue as in FIG. 1(c), or directed in anotherdirection.

Accuracy of the optical interrogation may be enhanced by configuring thejaws to close in a parallel manner as shown in FIG. 6, with theirseparation distance (and thus the separation distance between thetransmitting window/aperture and the receiving window/aperture) beingknown to a high degree of precision.

In a variation shown in FIG. 1(d), the optical fibers are clipped to orgrasped by the jaw members, or clipped to a probe, rather than beingintegrated with the instrument. These fibers might extend down or alonga trocar through which the instrument is passed, or down an externalsleeve around the instrument. In these embodiments, the instrument ortrocar may be reusable, or they might be disposable, saving instrumentcosts by allowing the use of reusable fiber optic components withdisposable instruments.

The window/aperture for receiving reflected or transmitted light fortransmission to the image sensor may be oriented towards the opposingjaw, or forward looking, or oriented in another direction. When both thelight-receiving and light-transmitting apertures/windows faces theopposing jaw, tissue information can be obtained when the jaws are usedto grasp tissue. Light is transmitted from jaw 22 b into the graspedtissue. Light transmitted through the grasped tissue passes into theoptical fiber(s) 17 a of the other jaw 22 a and are transmitted throughthe drape to the image sensor 18.

FIG. 1(e) shows an embodiment of the type shown in FIG. 1(a) adapted foruse with a surgical robotic system similar to the Senhance™ SurgicalSystem marketed by TransEnterix, Inc., Morrisville, N.C. The figureshows the distal portion of a robotic manipulator arm 30 which operatesunder the control of a command console (not shown) operated by thesurgeon. The robotic manipulator has a terminal portion designed tosupport and operate a surgical device assembly 32. The surgicalinstrument 32 is removably mountable at its proximal housing 34 onto themanipulator arm 30. In this drawing, the surgical instrument 32 and themanipulator arm are shown separated to allow relevant features to beseen.

Sterile drapes are barriers are used to cover non-sterile components.The robotic arm 30 is typically provided non-sterile and thus is coveredwith a sterile drape 36. The surgical instrument (shaft and endeffector) is provided as a sterile component, and in some cases thehousing 34 of the surgical device assembly is also a sterile componentand can be mounted directly onto the drape 36. In other cases, thehousing 34 contains motors or sensitive electronics and thus cannot besubjected to sterilization processes. In those cases, a second sterilebarrier 38 such as a sterile bag is positioned around the housing 34before it is mounted onto the robotic arm. Motion to actuate features ofthe surgical instrument (e.g. jaw open-close, bending or articulation)may be driven by motors in the arm and mechanically transmitted acrossthe drape, and/or it may be driven by motors in the housing. Otherfeatures of the system are found in US 20160058513, U.S. Pat. Nos.9,350,934, 9,358,682 and US 2013/0012930.

A source of light 16 and an optical sensor 18 are positioned on the arm.These components might be integral with the arm or they might becomponents of an optical module 15 removably positioned on themanipulator arm 30. Power for these components may be provided via themanipulator arm.

The instrument may be configured as described with respect to FIGS.1(a)-1(d). During use, the housing 34 of the surgical instrument ismounted on the manipulator arm 30. When optical interrogation is to becarried out, light from the source 16 is transmitted across the one ormore sterile barriers 36, 38 and is received by an optical fiber or abundle of optical fibers 17 b which carry the light to the distal partof the surgical instrument 32. Light reflected or transmitted onto thetip of the instrument is received by an optical fiber or a bundle ofoptical fibers 17 a running through the instrument shaft and istransmitted to the image sensor 18. The drape(s) may be constructed inits entirety of a material having suitable optically transmissiveproperties, or it might include a window formed of material havingsuitable optically transmissive properties.

While some embodiments use jaws, other embodiments do not include jaws;others may include jaws but use only one jaw in the performance of theoptical interrogation methods described here. In these embodiments, bothapertures/windows are on a single probe or jaw and arranged so thatlight from the light-emitting aperture/window is reflected off of tissuein the operative site and reflected light passes into thelight-receiving aperture/window for communication to the image sensor(or, in the case of fluorescence, light is absorbed by tissue and lightsubsequently emitted by the tissue is received into the light-receivingwindow/aperture).

In still other embodiments, the illumination element and the receivingelement are on different devices. For example, light may be emittedlocally by the instrument but received by another device such as theendoscope, the trocar, or another device, or light may be emitted by aseparate device and received by the surgical instrument.

In a second embodiment shown in FIG. 2, optical interrogation isintegrated into a robotically controlled surgical instrument in analternative configuration. In this embodiment, the light-transmittingfibers (which carry the light used to illuminate tissue away from thelight source) and the light-receiving fibers (which carry light receivedfrom the tissue towards the sensor) are attached using fiber opticcables to the respective modules that house the illumination source andthe image sensor. The cables extend from a proximal part of the surgicalinstrument and/or are attached to the proximal part of the instrumentusing fiber optic couplers. In the drawing, an instrument actuationassembly 26 at the proximal part of the instrument includes couplingsfor receiving the distal ends of the cables as shown. In a slightmodification to this embodiment, fiber optic connectors are used foreither the connection between light source and its associatedlight-transmitting fibers or for the connection between the sensor andits associated light-receiving fibers. The other connection is made viatransmission through the drape in a manner similar to that shown in FIG.1(a).

The instrument shaft may be one of a variety of types that may have itsposition and/or orientation controlled by actuators of the roboticsurgical system. Exemplary shaft types include rigid shafts, continuumrobotic or bendable shafts, shafts having discrete articulating joints,or shafts with articulating wrists or other articulating elements. Therobotic system may be one that communicates motion from drive mechanismsof an actuation drive assembly (motor module) 28 disposed on one side ofa surgical drape 20 to driven mechanisms of the instrument in theinstrument actuation assembly 26. One such configuration is shown inpublished PCT Application No. WO 2016/057989 which is incorporatedherein by reference.

The FIG. 3 embodiment also shows integration of optical interrogationinto a robotically controlled surgical instrument. In this embodiment,the light source and sensor components are separate from the instrument,and may be in one or two modules or housings that mount to a part of theinstrument, such as at the actuation assembly 26. A battery pack may beused to supply power to the interrogation system. As in the FIG. 2embodiment, the surgical robotic actuation drive assembly 28 may be onethat communicates motion through the drape, allowing the motor module toremain outside the sterile field.

The illumination and/or sensing may be carried out using instrumenttypes other than those shown in the drawings. For example, a trocarpositionable in an incision for receiving surgical instruments may beequipped to illuminate the tissue and/or communicate the light reflectedor transmitted from the tissue or fluorescent agent to the sensor.

FIGS. 4 and 5 show alternatives to the optical fiber configurationsdiscussed above. In FIG. 4, a single optical fiber is used as both thelight-transmitting fiber and the light-receiving fiber. This embodimentmakes use of a dichroic mirror or tunable filter to create theappropriate pathways for each type of light, as shown. This embodimentmay be particularly suitable where the optical interrogation relies onadministration to tissue of a fluorescent agent that fluoresces at awavelength that is different from the illumination wavelength emitted bythe light source. The dichroic mirror or tunable filter can beconfigured to reflect light from the light source into the opticalfiber, and to transmit light from the optical fiber through themirror/filter onto the sensor. In a variation of this embodiment, thearrangement of the light source and sensor are reversed (with acorresponding reconfiguration of the dichroic mirror/tunable filter).

FIG. 5 shows a fiber arrangement that carries out both reflectance andtransmittance, including diffuse-reflectance spectroscopy (DRS). In theembodiment that is shown, the fiber arrangement for the instrumentincludes a light-transmitting or “illuminating” fiber that transmitslight to the tissue, and a plurality of light-receiving or “sensing”fibers. The ratio of illuminating fibers to sensing fibers might be 1:1up to 1:many. The fibers may run adjacent to one another as shown. Amodification of this embodiment uses broad area illumination incombination with multiple sensing fibers. In still other embodiments,the sensing fiber(s) are arranged to obtain reflected light from asingle spot of interest, an area of interest, or multiple points of anarea (similar to an imaging approach).

In other embodiments, the number and arrangement of illuminating fibersrelative to the sensing fibers may be reversed from what is describedwith respect to FIG. 5, with the illuminating fibers taking the place ofthe sensing fibers and vice versa.

FIG. 7 shows an optical interrogation instrument 40 used to conductinterrogation of tissue along an edge or tip of a surgical instrument.In the illustrated embodiment, the instrument includes a pair of jawmembers 42. At least one of the jaw members includes at least oneoptical sensing fiber which conducts light to a detector. The sensingfibers are arranged to detect light from a single point of measurement,multiple discrete measurement points, or a continuous measurement orfeedback area. The light emitter may also be on the jaw member or it maybe on a separate instrument such as a trocar that receives theinstrument 40 or a separate instrument. In other embodiments, the jawmember will include the light emitter only, in which case the lightdetector is positioned on a separate instrument. As can be seen in thedrawing, these elements are positioned so that receipt of reflectedlight occurs along the exterior edge of the jaw (as opposed to the edgethat opposes the other jaw), allowing for tissue interrogation when theexterior edge contacts tissue during blunt dissection. In modifiedversions of the FIG. 7 embodiment, the jaw members are replaced withanother type of instrument such as a probe such as, for example, amonopolar dissecting hook. Information obtained using this device may becommunicated to the user in the manner described in commonly-owned U.S.application Ser. No. 15/917,897, or in another way.

All patents and patent applications referred to herein, including forpurposes of priority, are incorporated herein by reference.

What is claimed is:
 1. A surgical method comprising: removablypositioning a sterile barrier on a manipulator arm; removablypositioning a surgical instrument on the manipulator arm such that thesterile barrier is positioned between a portion of the manipulator armand a portion of the surgical instrument; introducing a distal end ofthe surgical instrument into a body cavity, and positioning a portion oftissue between first and second jaw members of the surgical instrument,transmitting light to the portion of tissue from a first optical fiberhaving a distal end exposed on the first jaw member, receiving lightfrom the portion of tissue at a second optical fiber having a distal endexposed on the second jaw member, and transmitting the received light toa sensor.
 2. The method of claim 1, further comprising: removablypositioning a sterile barrier on a manipulator arm, the sterile barrierhaving an optically transmissive portion; removably positioning thesurgical instrument on the manipulator arm such that the sterile barrieris positioned between a portion of the manipulator arm and a portion ofthe surgical instrument; wherein transmitting light to the tissue fromthe first optical fiber includes transmitting light from the manipulatorarm across the optically transmissive portion of the barrier to thefirst optical fiber.
 3. The method of claim 2, wherein the light sourceis positioned on the manipulator arm, and wherein removably positioningthe sterile barrier on the manipulator arm includes positioning thesterile barrier with the optically transmissive portion covering atleast a portion of the light source.
 4. The method of claim 2, whereinthe optically transmissive portion of the barrier is a window in thebarrier formed of optically transmissive material.
 5. The method ofclaim 2, wherein the barrier is constructed in its entirety of opticallytransmissive material.
 6. The method of claim 1, wherein a processorreceives from the sensor signals that are indicative of the lightdetected by the sensor and analyzes the signals to derive or determinetissue information.
 7. The method of claim 6, wherein the tissueinformation is tissue differentiation information, tissue typeinformation, tissue density information, tissue pathology information,or information indicating inflammation, ischemia, or blood vesselpresence (via transmittance loss, hemoglobin detection, or blood flowdetection).
 8. The method of claim 2, wherein the sensor is disposed onthe manipulator arm, and wherein receiving light from the portion oftissue and transmitting the received light to the sensor includestransmitting the received light across the sterile barrier to thesensor.
 9. The method of claim 1 wherein the sensor is positioned on thesurgical instrument, and wherein receiving light from the portion oftissue and transmitting the received light to the sensor includestransmitting the received light to the sensor.
 10. The method of claim2, further including using the first or second optical fiber to deliveroptical treatment energy.
 11. The method of claim 1, wherein thereceived light is light reflected from the portion of tissue.
 12. Themethod of claim 1, wherein the received light is light emitted by theportion of tissue.